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NCT00635193 · ClinicalTrials.gov registry record · Phase 1
Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)
A Phase 1 study, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 1
- Development phase
- 138
- Enrollment target
NCT00635193 is a Phase 1 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 138 participants.
The verdict
NCT00635193, a Phase 1 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 138 participants
- Enrollment target
Study Summary
This is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft models. In clinical studies, volociximab has been evaluated in several solid tumor types, including pancreatic, renal, and melanoma, with many subjects who entered the studies with progressive disease remaining progression-free for several months. In all studies in solid tumors, volociximab has shown a favorable safety profile when administered at 10 mg/kg q2wks and more recently at 15 mg/kg qwk. A study of volociximab in combination with liposomal doxorubicin in subjects with ovarian cancer or primary peritoneal cancer who have relapsed after prior platin/taxane therapies is warranted to further evaluate the drug's efficacy and safety. The investigators have thus far activated stage 2 of this study at 11/25 sites. Worldwide, the study aims to enroll 150 subjects.
Interventions
- DRUG Liposomal Doxorubicin
- DRUG M200 (Volociximab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00635193
The ClinicalTrials.gov registry entry for NCT00635193 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie (prior sponsor, Abbott), which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Liposomal Doxorubicin is the first listed.
NCT00635193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00635193 about?
NCT00635193 is a clinical study titled "Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)". This is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic integrin inhibitor being de...
What is the current status of trial NCT00635193?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 138 participants. The study started on 2007-07. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00635193?
The interventions under investigation include: Liposomal Doxorubicin (DRUG), M200 (Volociximab) (DRUG).
Who is sponsoring clinical trial NCT00635193?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
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